|Aantal uren per week||40 uur|
Elekta is looking for an experienced, expert and collaborative Quality Engineer to drive process excellence and compliance. Apply!
Focus on valuable process improvements and compliance for a company that develops and engineers life-saving cancer solutions
Elekta is the leading innovator of equipment and software designed to improve, prolong and save the lives of people with cancer and brain disorders. In the Netherlands we constantly work to innovate and improve equipment and software for brachytherapy, a means of delivering High Dose Rate radiotherapy with optimized accuracy and minimal invasiveness. What could be more rewarding than playing a key role in monitoring and improving the processes that make it all possible?
Veenendaal, the Netherlands, 40 hours per week
You will join a dedicated and expert Quality Assurance (QA) team of four which acts as a powerful advocate for Quality, promoting Elekta’s vision and mission while supporting the goals of the overall business. In doing so you help process owners to define and implement processes and system changes whilst also analyzing process improvements to drive efficiencies. This brings you into close contact with all areas of the company as you work with Engineering, Order Fulfillment, Regulatory Affairs, Sales & Marketing, and Manufacturing among others.
Detailed tasks include:
- Analyzing process data and trends;
- Preparing monthly metrics for your area of expertise and responsibility;
- Representing the Operational Audit organization in specific processes (e.g. CAPA, Order fulfillment, Manufacturing, etc.);
- Supporting others in the Operational Audit organization and other functional organizations on technical aspects;
- Participating in external audits before regulatory authorities and participating in the execution of the internal audit plan.
All of this requires a structured approach to problem solving, a deep understanding of quality tools and techniques, and the ability to translate regulations into meaningful business requirements. You should also be objective-driven and customer-focused, able to deliver solutions for the business while working autonomously and to tight deadlines.
Combining effectiveness with sensitivity
As a Quality Engineer at Elekta you interact with individuals and teams across the company in order to ensure the highest levels of process quality. Moreover, you will be operating in a highly demanding regulatory environment. It is therefore essential that you are able to involve others by enthusiastically communicating the value and necessity of improvements and compliance in a spirit of openness and collaboration. These advanced ‘people skills’ are particularly relevant for the Operational Audit organization, where you must be able to listen to others while standing your ground and accelerating the necessary processes. The QA team shares their office with the Regulatory team of 6 people, together representing the local QA/RA department.
You will be part of an extended QA network of colleagues in Sweden, US and UK that maintains close contact and constantly seeks to learn from each other. Most of this communication is in English, as are all global regulations and procedures, so you should have strong English language skills.
Can you bring the valuable skills we are looking for?
In order to apply for this wide-ranging and highly-responsible position you should possess the following personal and professional attributes:
- Bachelor's degree in Engineering or its equivalent in a related field, or a formal engineering apprenticeship with demonstrable experience in a similar role;
- Training and experience in relevant medical device regulatory requirements and standards (e.g. ISO, IEC, MDD, OSR, CMDR) and, ideally, quality professional certifications (e.g. COl, COMOE, COA, COE.);
- Experience in quality improvement tools and techniques is a plus (e.g. Lean, Six Sigma, DOE, Statistical Methods, etc.);
- Proven experience in relevant areas of Quality, Regulatory or Engineering, with experience of a medical device environment a significant advantage;
- Able to communicate in confidence with all levels via strong written and verbal English language skills, with languages such as German and Spanish a plus.
- Able to travel on an occasional basis.
An attractive offer from a great organization
Elekta is a flexible and forward-thinking international organization that is fully focused on the wellbeing of our employees. You will enjoy a flexible and informal working environment as well as Learning and Development opportunities that will enable you to progress in your career. You will benefit from an attractive salary as well as:
- Profit-sharing arrangement: max 16% on a yearly basis (9% average in recent years);
- 27 vacation days and 13 ADV days per year;
- Travel allowance for home-work travel;
- Tax-advantageous fitness package;
- Good company restaurant and regular opportunities to socialize within the company.
We look forward to hearing from you
Please contact Rigo Meens, Head of QA, for more information about this position, phone number +31 (0)318 557 133. For more information about the application procedure, you can contact Arjette Poot, phone number +31 (0)318 557 130. To apply, please click on the "Apply" button.
Elekta is proud to be the leading innovator of equipment and software used to improve, prolong and save the lives of people with cancer and brain disorders. Our advanced, effective solutions are created in collaboration with customers, and more than 6,000 hospitals worldwide rely on Elekta technology. Our treatment solutions and oncology informatics portfolios are designed to enhance the delivery of radiation therapy, radiosurgery and brachytherapy, and to drive cost efficiency in clinical workflows. Elekta employs 3,600 people around the world. Headquartered in Stockholm, Sweden, Elekta is listed on NASDAQ Stockholm. www.elekta.com.
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